Comparison of Liquid Kaletra and Low Dose Kaletra Tablets
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Purpose
Kaletra is one of a few effective medications that are approved and available for young children who are HIV+. The liquid form is reported to have a very nasty taste and presents difficulties for the children who must take the medication twice a day and for their parents who must enforce the medication regimen. The children are often well into their teens before they weigh enough to be able to take the adult dose tablet. A new smaller dose tablet (100mg) is now available. However, it is not known if the liquid and tablet act the same in children. The purpose of this study is to switch children from the liquid to the 100mg tablet form of Kaletra. The study will compare children pre-switch and post-switch in terms of how well controlled their HIV is. Comparisons of weight gain, and changes in appetite, nausea, vomiting, adherence and parent/child satisfaction will also be made. Eight to 10 HIV+ children currently well managed with a medications including liquid Kaletra will be invited to switch from the liquid to the low dose Kaletra tablet. The parent and/or child will complete a satisfaction survey for the liquid Kaletra and lab values will be taken from the chart. At the time of the switch and 1, 3 and 6 months post switch blood tests will be drawn and the parent and/or child will complete the satisfaction survey. In addition, at the switch and 1 month post switch, a day will be spent in clinic with 5 blood draws to see how much of the drug is in the blood stream at different times after the medicine is taken.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Low dose Kaletra tablets |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison of Liquid Kaletra and Low Dose Kaletra Tablets in HIV-Positive Children |
- CD4 and Viral Load [ Time Frame: Baseline, 1 month, 3 months, 6 months ] [ Designated as safety issue: Yes ]
- Lopinavir CMax [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]Cmax values at baseline and week 4
- Lopinavir AUC [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]Area under the curve values for lopinavir at baseline and week 4
- Lopinavir AUC ratio of baseline:week 4 [ Time Frame: Baseline, week 4 ] [ Designated as safety issue: No ]Ratio of AUC at baseline (liquid)to week 4 (reduced dose tablet)
- Patient Satisfaction [ Time Frame: Baseline, 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]
- Symptoms [ Time Frame: Baseline, 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 8 |
| Study Start Date: | October 2008 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Low dose Kaletra
Patients will serve as their own controls as they are switched from liquid Kaletra to Low Dose Tablet Kaletra
|
Drug: Low dose Kaletra tablets
Lopinavir/Ritonavir tablets 100mg/25mg
Other Name: lopinavir/ritonavir 100mg/25mg
|
Eligibility| Ages Eligible for Study: | 3 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV+ children aged 3-18.
- currently on a stable (on same regimen > 3 months, VL< 5,000), HAART regimen containing liquid Kaletra
- able to take pills or willing to undergo pill training prior to enrollment
- weight must be greater than or equal to 15kg
Exclusion Criteria:
- Unable to swallow pills
- Concomitant treatment with Rifampin or St. John's Wort which have been shown to decrease plasma concentrations of lopinavir.
- Concurrent use of drugs primarily metabolized by CYP3A, which metabolizes ritonavir: Astemizole, Cisapride, Dihydroergotamine, Ergonovine, Ergotamine, Flecainide, Lovastatin, Methylergonovine, Midazolam, Pimozide, Propafenone, Simvastatin, terfenadine, Triazolam.
Contacts and Locations| United States, Arizona | |
| Phoenix Children's Hospital | |
| Phoenix, Arizona, United States, 85016 | |
| Principal Investigator: | Janice Piatt, MD | Phoenix Children's Hospital |
More Information
No publications provided
| Responsible Party: | Janice Piatt, Medical Director, Bill Holt Clinic, Phoenix Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT00762320 History of Changes |
| Other Study ID Numbers: | 08-017 |
| Study First Received: | September 29, 2008 |
| Last Updated: | December 19, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Phoenix Children's Hospital:
|
HIV Kaletra treatment Experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Ritonavir |
Lopinavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013